MAUDE Adverse Event Report: MAQUET SAS VOLISTA ACCESS; LIGHT, SURGICAL, CEILING MOUNTED

Catalog Number ARD568805906

Device Problem Overheating of Device (1437)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/06/2019

Event Type  malfunction  

Manufacturer Narrative

The issue is still being investigated by manufacturing site.(b)(4).

Event Description

On (b)(6) 2019 maquet sas became aware of an issue with volista surgical light.As it was stated, light head produced an enormous heat, which may lead to adverse outcome.There was no injury reported however we decided to report the issue in abundance of caution as heat may lead to an injury.Manufacturer reference number (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.

Event Description

Manufacturer reference number: (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.(b)(4).Exemption # e2018005.(b)(4).

Event Description

Manufacturer reference number (b)(4).

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

Getinge usa sales, llc (importer) is submitting this report on behalf of the legal manufacturer of the device maquet sas (b)(4).The issue is still being investigated by manufacturing site.Information about the customer involved was received and is included.

Manufacturer Narrative

Getinge became aware of an issue with volista surgical light.As it was alleged by the user, the light head produced an enormous heat.There was no injury reported however we decided to report the issue in abundance of caution as heat may lead to an injury.It was established that when the event occurred, the light head did not meet its specification and it contributed to the event.At the time when the event occurred the device was not being used for the patient treatment.The issue was investigated by a subject matter expert.It was found that the customer feedback received was subjective and could not be reproduced and objectively measured.We concluded that the issue could be related to subjective feeling of the user or issues with air conditioning of the affected room.Given the circumstances and the fact that there is no apparent trend in the complaints we shall continue to monitor for any further events of this nature and do not propose any further action at this time.

Event Description

Manufacturer reference number 2019-63202.

• Brand Name: VOLISTA ACCESS
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 8582361
• MDR Text Key: 144146418
• Report Number: 9710055-2019-00164
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Inspection
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ARD568805906
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1